Operation and Maintenance of Gel Filling Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel filling machine to ensure accurate filling of gel products with consistent quality.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the gel filling machine in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the gel filling machine.

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the filling process.
2. Verify the availability and integrity of gel formulation and packaging materials (tubes, containers).
3. Inspect the gel filling machine, including filling nozzles and conveyor system, to ensure they are clean and operational.

4.2 Filling Process

1. Set up the filling parameters such as fill volume, speed, and accuracy according to the gel formulation specifications.
2. Prime the filling nozzles and adjust settings to minimize air bubbles and product waste.
3. Start the filling process and monitor for consistent fill volumes and proper sealing of packaging.

4.3 Cleaning and Maintenance

1. Stop the gel filling machine after completing the filling batch.
2. Disassemble filling components for thorough cleaning and sanitization.
3. Perform routine maintenance tasks such as lubrication of moving parts and inspection of seals.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Formulation record

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for gel filling machine

8) SOP Version

Version 1.0